Cleared Traditional

TREATMENT TABLE

K910838 · Tri W-G, Inc. · Radiology
Aug 1991
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K910838 is an FDA 510(k) clearance for the TREATMENT TABLE, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on August 7, 1991, 161 days after receiving the submission on February 27, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K910838 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1991
Decision Date August 07, 1991
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

Similar Devices — IXR Table, Radiographic, Tilting

All 76
VISION R/F TILTING TABLE
K000412 · Villa Sistemi Medicali S.P.A. · Apr 2000
LEGACY/LEGACY-D TABLE
K973039 · GE Medical Systems · Oct 1997
CAP-35B III/CINE 275
K971128 · Jamieson Film Co. · Apr 1997
PHILIPS EASY DIAGNOST
K970640 · Philips Medical Systems North America, Inc. · Mar 1997
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K965105 · U.S. Imaging Tables, Inc. · Jan 1997
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
K965096 · U.S. Imaging Tables, Inc. · Jan 1997